Drug recall
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO…
FDA recall event 77789 · Class II · Orthofix Srl
Key facts
| Event ID | 77789 |
|---|---|
| Recall numbers | Z-0291-2018 |
| Recalling firm | Orthofix Srl |
| Product type | Devices |
| Products | Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The power drill torque limiter may break during use in surgery application. |
| Initiation date | Jul 5, 2017 |
| Report date | Jan 3, 2018 |
| Termination date | Jan 13, 2023 |
| City | Bussolengo |
| Country | Italy |
| FEI number | 3002807827 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: